BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    MDR report key: 15395297 · Received September 9, 2022

    Report

    Report Number
    3013756811-2022-98067
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 20, 2022
    Report Date
    August 20, 2022
    Manufacturer
    TANDEM DIABETES CARE
    Product Code
    QFG
    UDI-DI
    00850006613762
    PMA / PMN Number
    K201214
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    TANDEM¿S PUMP USER GUIDE DESCRIBES HOW TO REMOVE AIR FROM THE CARTRIDGE USING THE SYRINGE. PER TANDEM¿S T:SLIM X2 WITH CONTROL-IQ USER GUIDE: "RESIDUAL INSULIN REMAINING IN THE CARTRIDGE (UNUSABLE)" NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTERMITTENT OCCLUSION ALARMS OCCURRED. ADDITIONALLY, IT WAS REPORTED THAT AIR BUBBLES WERE OBSERVED IN THE INFUSION SET TUBING. REPORTEDLY, THE CUSTOMER REUSED INSULIN AND DID NOT PRACTICE PROPER CARTRIDGE AIR REMOVAL TECHNIQUE. TANDEM TECHNICAL SUPPORT EDUCATED CUSTOMER REGARDING CARTRIDGE/INSULIN LABELING. REPORTEDLY, THE PUMP SUPPLIES WERE CHANGED TO ADDRESS THE ISSUE. CUSTOMER'S BLOOD GLUCOSE RANGED FROM 232-305 MG/DL. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1138867 T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY ALTERNATE CONTROLLER ENABLED INFUSION PUMP QFG TANDEM DIABETES CARE 1002717 00850006613762

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Female INFUSION SET: TRUSTEEL, INSULIN: NOVOLOG/NOVORAPID